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Biocides | June 3, 2020

We received lots of replies regarding our last blog post yesterday.

Among other things you were asking us if we can translate the official notice from The Slovene Chemical office. You can now read English translation of Slovene official notice here bellow:

"With the declaration of the revocation of the COVID-19 epidemic in Slovenia, which enters into force on 31 May 2020, the Office no longer notifies biocidal products under the simplified procedure from 1 June 2020 onwards. The Office will process applications received within the regular legal deadlines. 

The Office will continue to accept applications for notification of PT1 and PT2 disinfectants containing ethanol at a concentration of more than 76% v/v (70% w/w) for PT1 and more than 70% v/v (63% w/w) for PT2 without proof of effectiveness but will approve them exclusively for the effect on enveloped viruses. As of 1 June 2020, the Ordinance on the use of ethanol in disinfectants (Official Gazette of the Republic of Slovenia, No. 40/20) also expires, so from that day it is no longer possible to notify ethanol-based disinfectants, the manufacturer or importer of which is not included in the list referred to in the first paragraph of Article 95 of Regulation (EU) No. 528/2012.

For disinfectants approved at the time of the COVID-19 epidemic under the simplified notification procedure, the applicant may extend the range of pests or the PT with an application to amend the notification and with appropriate efficacy tests provided that the supplier of the active substance is listed in Article 95 of the Regulation (EU) No. 528/2012. The application form for notification is used for the amendment. The fee to submit such an amendment is 90 EUR.

When notifying disinfectants with other active substances for which the applicant wishes to indicate an effect on viruses, the applicant is required to submit efficacy tests with a proven antiviral or enveloped antiviral effect. The effect must be tested and demonstrated according to EN 14476, 14675 and 16777 respectively according to the scope, taking into account the Guidelines of the European Chemicals Agency, in particular Chapters 5.4.1 and 5.4.2, which can be found at the following link.

An extraordinary permit for disinfectants with active substances already assessed at EU level is issued by the Office only in cases where an assessment is submitted by the National Institute of Public Health (NIJZ) or another health institution that it is an urgent and justified disinfection that cannot be performed with other already approved alternatives. The Office shall decide on the issue of licenses on the basis of the actual demonstrated need, and provided that the product meets the requirements of Article 19 of Regulation (EU) No. 528/2012.

If a greater need for disinfectants is demonstrated again, the Office will adopt additional criteria and re-adjust the supply and availability of biocidal products - disinfectants to the needs in Slovenia."

As always, should you need assistance in notifying biocides, feel free to contact us at any time.

We will guide you through the entire process and make sure you have the products on the market as quickly as possible.

 

 

 

 

Disclaimer:
Information on this blog is prepared with utmost care, but it is not about (chemical) consulting, and the provider does not assume any responsibility or liability for the correctness, accuracy and up-to-dateness of published content. If you need advice for a specific case, you can write to us at bojan.dimic@bens-consulting.com

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